Methods for positioning a load-bearing component of an orthopedic implant device by inserting a malleable device that hardens in vivo

ABSTRACT

A device is provided that is non-rigid, i.e., flexible and/or malleable, in a first form, and then transformable after insertion to an in vivo site into a rigid, or hardened, form; a cure-initiating energy is applied to the device; and the device is then positioned in the in vivo site where it hardens to provide a load-bearing function or other structural and/or mechanical function. The device includes a biocompatible sheath and a curable material sealed within the sheath. The curable material is provided in a first form that provides flexibility to the device and is structured to rigidize in a second form after application of a quantity of an initiating energy to the material.

BACKGROUND

The present application relates to the field of orthopedic implants andmanners of positioning same at desired in vivo locations. Moreparticularly, the application relates to devices, systems and implantsfor treatment of spinal deformities and conditions, or other skeletaldeformities and conditions. The devices can be used to treat eitherchronic or acute conditions.

The use of prosthetic implants to address orthopedic injuries andailments has become commonplace. While bone wounds can regenerate,fractures and other orthopedic injuries take a substantial time to heal,during which the bone is unable to support physiologic loads. It is wellunderstood that stabilization of adjacent bony portions can be completedwith an implant positioned between the bony portions and/or an implantpositioned along the bony portions. A wide variety of orthopedic implantdevices are known that are designed to provide structural support to apatient's spine or other bone or joint. The implants can be rigid toprevent motion between the bony portions, or can be flexible to allow atleast limited motion between the bony portions while providing astabilizing effect. As used herein, bony portions can be portions ofbone that are separated by one or more joints, fractures, breaks, orother space. Implants can be positioned, for example, for use in rigidposterior spinal fixation systems, such as rods, plates, tethers andstaples; for use in interbody spinal fusion or corpectomy; for use indynamic spinal stabilization; or for rigid or dynamic stabilization ofother bones or skeletal joints. In addition, pins, screws and meshes arefrequently used in devices that replace the mechanical functions ofinjured bone during the time of bone healing and regeneration.

In this arena, it is often desired to decrease the invasiveness ofimplant placement procedures, improve implant integrity, and providemore positive patient outcomes. Particularly, it is often desired toprovide an implant with reduced dimensions and/or flexiblecharacteristics to facilitate implantation while also providingsufficient rigidity to provide support for corrective treatment.Unfortunately, current devices can be limiting in certain applications.Thus, there is a need for additional contributions in this area oftechnology.

SUMMARY

The present application provides methods for positioning orthopedicimplant devices that are malleable and/or flexible during the implantprocedure and then hardened at the site of the implant. Thus, theapplication involves the insertion of a device that has a first statethat provides more flexibility and/or malleability than a second state.Other aspects include unique systems, devices, instrumentation, andapparatus involving placement of an orthopedic implantable device.

In one aspect of the application, there is provided a method forpositioning a load-bearing component of an orthopedic implant thatincludes: (1) providing a malleable device, the device including abiocompatible sheath and a curable material sealed within the sheath,the device having a non-rigid form and being transformable to a rigidform after application of a quantity of an initiating energy to thematerial effective to cure the material; (2) applying a dose of theinitiating energy to the material; and (3) after said applying,inserting the device to an in vivo location where the provision ofload-bearing functionality is desired.

In another aspect of the application, there is provided a method forpositioning a load-bearing orthopedic implant, including: (1) providinga malleable device including a curable material contained within abiocompatible sheath and an energy delivery element contained within thesheath; (2) initiating curing of the curable material by exposing thecurable material to a quantity of initiating energy from the energydelivery element effective to initiate curing; and (3) after saidapplying, positioning the device in an in vivo position.

In yet another aspect of the application, there is provided a method forpositioning a load-bearing orthopedic implant, including: (1) providinga malleable device including a biocompatible sheath and a curablematerial contained therein that is hardenable by exposing the curablematerial to a quantity of initiating energy effective to fully cure thematerial, wherein the initiating energy is electromagnetic radiation ofa predetermined wavelength, and wherein the sheath is translucent ortransparent to the radiation; (2) initiating curing of the curablematerial by passing radiation of the predetermined wavelength throughthe sheath to expose the curable material to a dose of initiating energyeffective to initiate curing; and (3) after said applying, positioningthe device in an in vivo position.

In another aspect, the application provides a method for positioning aload-bearing orthopedic implant that includes: (1) providing a malleabledevice including a biocompatible sheath and, contained within thesheath, a pressurizeable balloon and a curable material positionedexternal to the balloon; (2) initiating curing of the curable materialby exposing the curable material to a dose of initiating energyeffective to initiate curing; (3) after said applying, positioning thedevice in an in vivo position; and (4) after said positioning,introducing a pressurizing fluid into the balloon to pressurize theballoon and exert an outward pressure on the curable material and thesheath, thereby causing the device to engage adjacent structures.

In yet another aspect, the application provides a method for positioninga load-bearing orthopedic implant, including: (1) providing a malleabledevice including a curable material and an internal reinforcement membercontained within a biocompatible sheath; (2) initiating curing of thecurable material by exposing the curable material to a dose ofinitiating energy effective to initiate curing; and (3) after saidapplying, positioning the device in an in vivo position.

Further embodiments, forms, features and aspects of the presentapplication shall become apparent from the detailed description andfigures provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross sectional view of one embodiment of an implant device.

FIG. 2 is a side plan view of an extradiscal spinal implant systemrelative to the spinal column of a patient.

FIG. 3 is a side view of a bone anchor device of the spinal implantsystem of FIG. 2 with some features shown in phantom.

FIG. 4 is a side plan view of an adjustable configuration bone anchordevice according to an alternative embodiment of the bone anchor deviceof FIG. 2, with some features shown in phantom.

FIG. 5 is a side plan view of a bone anchor device of the spinal implantsystem of FIG. 2 with some features shown in phantom.

FIG. 6 is a side plan view of another embodiment bone anchor device ofthe spinal implant system of FIG. 2 shown in the context of a pre-formedcavity in a bony portion, which is shown in cross section.

FIG. 7 is a side plan view of the embodiment of FIG. 6 with the stem ofthe bone anchor device positioned in the pre-formed cavity.

FIG. 8 is a perspective view of an elongate spinal fixation elementdevice of the spinal implant system of FIG. 2, with some features beingshown in phantom.

FIG. 9 is a cross sectional view of the elongate spinal fixation elementdevice of FIG. 8 taken along view line 9-9 in FIG. 8.

FIG. 10 is a side plan view of a crosslink device which may be used withthe spinal implant system of FIG. 2 with some features shown in phantom.

FIG. 11 is a side plan view of an embodiment of an extradiscal plateimplant device.

FIG. 12 is a cross sectional view of the device of FIG. 11 taken alongview line 12-12 in FIG. 11.

FIG. 13 is a cross sectional view of the device of FIG. 11 taken alongview line 13-13 in FIG. 11.

FIG. 14 is a diagrammatic side plan view of an intradiscal implantdevice relative to the spinal column of a patient.

FIG. 15 is a sectional view of the implant device of FIG. 14 along viewline 15-15 of FIG. 14.

FIG. 16 is a perspective view of another embodiment intradiscal implantdevice with some features shown in phantom.

FIG. 17 is a side plan view of another embodiment intradiscal implantdevice with some features shown in phantom.

FIG. 18 is a perspective view of another embodiment intradiscal implantdevice with some features shown in phantom.

FIG. 19 is a perspective view of another embodiment intradiscal implantdevice with some features shown in phantom.

FIG. 20 is a partial cross sectional view of another embodiment of animplant device.

FIG. 21 is a partial cross sectional side plan view of anotherembodiment bone anchor device of the spinal implant system of FIG. 2,shown in the context of a pre-formed cavity in a bony portion, which isshown in cross section, wherein the stem of the bone anchor isconfigured to be transformed from an unexpanded form to an expandedform, said stem being depicted in this Figure in the unexpanded form.

FIG. 22 is a side plan view of the bone anchor embodiment depicted inFIG. 21 with the stem of the bone anchor device positioned in thepre-formed cavity in an unexpanded, unengaged form.

FIG. 23 is a side plan view of the bone anchor embodiment depicted inFIG. 21 with the stem of the bone anchor device positioned in thepre-formed cavity in an expanded, engaged form.

FIG. 24 is a longitudinal partial cross sectional view of anotherembodiment of an elongate spinal fixation element device of the spinalimplant system of FIG. 2.

FIG. 25 is a cross sectional view of another embodiment of an elongatespinal fixation device of the spinal implant system of FIG. 2.

FIG. 26 is a partial cross sectional view of another embodiment of animplant device.

FIG. 27 is a partial cross sectional view of another embodiment of animplant device.

FIG. 28 is a partial cross sectional view of another embodiment of animplant device.

FIG. 29 is a partial cross sectional view of another embodiment of animplant device.

FIG. 30 is a partial cross sectional view of another embodiment of animplant device.

FIG. 31 is a partial cutaway side plan view of another embodiment of animplant device.

FIG. 32 is a partial cross sectional view of another embodiment of animplant device.

FIG. 33 is a cross sectional view of an implant device contained withina package.

FIG. 34 is a partial cross sectional view of another embodiment of animplant device, connected to a power source.

FIG. 35 is a partial cross sectional view of another embodiment of animplant device, connected to a light source.

FIG. 36 is a partial cross sectional view of another embodiment of animplant device, together with a light source

FIG. 37 is a partial cross sectional side plan view of anotherembodiment bone anchor device of the spinal implant system of FIG. 2,shown in the context of a pre-formed cavity in a bony portion, which isshown in cross section, wherein the stem of the bone anchor isconfigured to be transformed from an unexpanded form to an expandedform, said stem being depicted in this Figure in the unexpanded form.

FIG. 38 is a perspective view of an implant device positioned within anenergy source.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinventions described herein, reference will now be made to theembodiments illustrated in the drawings and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of any invention is thereby intended. Anyalterations and further modifications in the illustrated embodiments,and any further applications of the principles described and illustratedherein are contemplated as would normally occur to one skilled in theart.

The present application provides implantable orthopedic prostheticdevices that are curable to a hardened form by application of aninitiating energy prior to implantation, but that remain malleable for aperiod of time after application of the initiating energy (referred toherein as the “working time”) to provide sufficient time for insertioninto a desired in vivo site and placement and formation into a desiredlocation and shape prior to becoming fully hardened. The device containsprecursors that are polymerized and/or cross-linked by a reaction thatis moderated to allow the device to remain malleable for the workingtime, before becoming hardened, at which time the device provides aload-bearing function or provides other structural and/or mechanicalfunction. Terms such as “hardenable” or “curable” are usedinterchangeably herein, and are intended to refer to any material thatcan be stably stored for an extended period of time in a first,malleable or flexible form without loss of flexibility, andtransitionable into a second, hardened form after application of aninitiating energy thereto. These terms are not intended to be limited toany specific mechanism of hardening. As will be understood by those ofskill in the art, a variety of hardening mechanisms can be utilized,depending upon material selection, including for example, curing that isinitiated by ultraviolet radiation, visible light, infrared radiation,radio frequency radiation, x-ray radiation, gamma radiation or otherwavelength of electromagnetic energy, catalyst-initiated polymerization,thermally-initiated polymerization, electrically-initiatedpolymerization, mechanically-initiated polymerization, curing initiatedby electron beam radiation and the like.

Orthopedic implants that include at least one malleable devicecontaining a hardenable material, and that are configured to be hardenedafter placement in a desired in vivo position by application of acure-initiating energy prior to implantation, find advantageous use in avariety of different circumstances. For example and without limitation,such implants can be used to advantage in circumstances in which it isdesirable for medical personnel to shape or re-shape a component duringthe course of an implantation procedure. The versatility also allows forless invasive technique for orthopedic implantation procedures, allowsfor greater design flexibility with regard to the implant device, andenables the avoidance of complications that can arise during a wet outor a two-part mixing process during surgery. The embodiments aredescribed primarily by reference to spinal devices; however, it isintended that the application be understood to encompass orthopedicdevices used in non-spinal locations as well. Orthopedic implants inaccordance with the application find advantageous use, for example, forstabilization of joints, such as hip or knee joints.

Devices contemplated by the application can be malleable, or flexible,prior to the time the curable material therein is exposed to an energysource that initiates curing of the material and for a working timethereafter during which the device is inserted to an in vivo location,and then assume a more rigid state after the device is in position. Withreference to FIG. 1, device 100 includes biocompatible sheath 110 andcurable material 120 contained and sealed in sheath 110. Curablematerial 120 has a non-rigid form, and is transformable to a rigid formafter application of a quantity of an initiating energy to material 120that is effective to cure material 120. When device 100 hardens, itbecomes a load-bearing component of an orthopedic implant having adesired shape and at a desired position. The component can be, forexample, a spinal rod, a plate, a spacer, a bone screw, an anchor, anartificial disk and a nucleus implant. Curable material 120 is sealedwithin sheath 110 so that injection or other handling or preparation ofcurable material during a surgical procedure can be avoided, if desired.

The primary functions of sheath 110 are to contain the curable material120 and to influence or control the shape of device 100, prior tocompletion of curing. Sheath 110 may comprise all or a portion of therespective implant device surrounding the curable material, and sheath110, either alone or in conjunction with other materials comprising thebody of a device, prevents contact of the curable material with hosttissues at least when the curable material is in a malleable form.Sheath 110 is not normally required to restrain pressure over anextended period of time. Thus, significant design flexibility may bepermitted. The material from which the sheath is made (also referred toherein as the “sheath material”) may be biostable or bioresorbable. Forexample, sheath 110 may be porous, which can be advantageous for drugdelivery or to permit osteoincorporation and/or soft tissue ingrowth.Alternatively, sheath 110 can be designed to have an active agentadsorbed thereon. In yet another alternative form, sheath 110 can becomposed of a biodegradable material, optionally having one or moreactive agents impregnated therein, that is absorbed by natural processesover time after implant. Sheath 110 can be constructed in any of avariety of ways, and may be made out of a wide variety of woven ornonwoven fibers, fabrics, metal mesh such as woven or braided wires, andcarbon. Examples of suitable biocompatible sheath material include, forexample, polyethylene (PE), polyethylene terephthalate (PET), polyamide,polyurethane, polylactic acid (PLA), PLDLA, ePTFE and Dacron™, to name afew. Other materials from which the sheath can be made includepolyester, silicone, polyetheretherketone, polyacrylate, polylactide andpolyglycolide. The material can be formed into a variety of forms,including, for example, sheets, tubing, balloons, pouches and fabric, toname a few.

In one embodiment, sheath 110 is energy permeable, and structured suchthat energy from an energy source external to the device can passtherethrough to contact curable material 120 and initiate curingthereof. In an exemplary embodiment, when curable material 120 is of atype that cures upon exposure to thermal energy, sheath 110 may comprisea biocompatible material that conducts heat and is capable of sealinglyenclosing curable material 120. Curing is preferably achieved at atemperature of from about 20° C. to about 70° C. In another embodiment,the curable material comprises a photocurable material that cures whenexposed to light or other electromagnetic radiation that passes throughthe sheath. For such embodiments to cure thoroughly, it is importantthat the sheath and the curable material itself have suitableproperties, such as, for example, transparency and/or translucency andthickness, such that the cure initiating energy can penetratesufficiently into the curable material to achieve sufficient curing. Ofcourse, a person skilled in the art will recognize that a degree ofcuring less than complete curing can be sufficient as long as the degreeof curing yields a device having sufficient load-bearing strength orsufficient strength for other mechanical function for which the deviceis used. It is, of course, also appreciated that a given sheath can beprovided that is transparent or translucent at certain selectedwavelengths of light or other electromagnetic radiation but not others.It is within the purview of a person skilled in the art to select asheath material and a curable material that are operable together.

To position a load-bearing component as provided herein a malleabledevice including a biocompatible sheath and a curable material sealedwithin the sheath is exposed to a dose of initiating energy and theninserted to an in vivo location where the provision of load-bearingfunctionality is desired. The device has a non-rigid form when exposedand inserted, and is transformable to a rigid form after it ispositioned in vivo. Examples of cure-initiating energy that can be usedinclude, for example, electromagnetic radiation, thermal energy,electrical energy, chemical energy and mechanical energy. Device 100depicted in FIG. 1 is deformable before and during implantation within apatient. Device 100 can be configured in a wide variety of shapes andsizes for a wide variety of end uses after curing of the curablematerial, such as, for example, as components of extradiscal spinalimplant systems, intradiscal spinal implant systems and implant systemsfor other regions of the body. Further detail regarding certainexemplary embodiments are provided with reference to the Figures, eachof which depicts an inventive device that includes a sheath surroundingor adjacent to one or more internal chambers, wherein the internalchamber(s) includes a curable material housed therein. The implantdevices illustrated in FIGS. 2-13 and 21-25 are examples of the manytypes, shapes, forms and configurations of extradiscal implant devicescontemplated by the present application, and each of the devices inFIGS. 14-19 are examples of intradiscal implant devices contemplated bythe present application. It should be appreciated that the featuresprovided herein can also be applied to other forms, shapes,configurations of other extradiscal implant devices.

With reference to FIG. 2, there is shown a device that includes anextradiscal spinal implant system 200 in side plan view relative to thespinal column SC of a patient. Spinal implant system 200 includes a pairof anchor devices 300, 301 and an elongate fixation element device inthe form of spinal rod 400. Furthermore, as will be appreciated by onehaving skill in the art, system 200 may include additional components,like for example, a crosslink device 500 as shown in FIG. 10. System 200may be used for treatment of several spinal deformities, including, butnot limited to, treatment of degenerative spondylolisthesis, fracture,dislocation, scoliosis, kyphosis, spinal tumor, and/or a failed previousfusion.

Anchor devices 300 and 301 are shown in side plan view in FIG. 3 withcertain features illustrated in phantom. Anchor devices 300 and 301,respectively, can each have an elongated shaft or stem 303 with boneengaging structures 304. Structures 304 may be in form of threads,spikes, barbs or other structure. A stem without bone engagingstructures is also contemplated. Stem 303 is structured to be positionedin and engage a passageway prepared in one or more bones or bonystructures in a standard manner, and can be provided with cutting flutesor other structure for self-tapping and/or self-drilling capabilities.Stem 303 can also be cannulated to receive a guidewire to facilitateplacement and may further include fenestrations or other openings forplacement of bone growth material.

Anchor devices 300, 301 can include a head or a receiver portion 305defining a receiving channel 306 between upright arms 307. Head orreceiver portion 305 can be fixed relative to stem 303 to provide auni-axial arrangement. Receiving channel 306 is sized and shaped toreceive spinal rod 400 and may include structures to engage engagingmembers 310, 311 for securing spinal rod to head 305, such as internalthreading along receiving channel 306 or external threading on head 305,both of which are not shown. In another embodiment, head 305 may includeany means for securing spinal rod 400 thereto as would be known to onehaving skill in the art. As illustrated, receiving channel 306 can beconcavely curved and form a passage having a shape of a portion of acircle to receive the rod in form fitting engagement therein. Otherembodiments contemplate that the rod is positioned against a proximalhead of the stem, or against a cap or crown adjacent a head of the stem,in receiving channel 306. It is further contemplated that receivingchannel 306 can be shaped in a variety of configurations to correspondto spinal rod 400 having a non-circular cross section, such as but notlimited to, an oval, rectangular, hexagonal, or octagonal cross section.

Referring now to FIG. 4, another embodiment anchor device 320 is shown.Anchor device 320 can be in the form of a stem portion 321 pivotallycaptured in head portion 322. Pivotal anchor device 320 may bemulti-axial, poly-axial, uni-axial, or uni-planar with respect to themanner in which stem portion 321 and head 322 are movable relative toone another. In one movable form, stem portion 321 and head 322 areengaged together with a “ball and joint” or swivel type of coupling thatpermits relatively universal movement therebetween during at least somestages of assembly.

In yet another form, implant system 200 may include bone anchors in theform of one or more hooks to engage an adjacent bony structure such as apedicle, lamina, spinous process, transverse process, or other bonystructure suitably engaged with a spinal hook. For instance, amulti-axial laminar hook form of a bone anchor can be used in place ofone or more of the anchor devices 300, 301. In still other embodiments,the bone anchor can include a bone attachment structure in the form of astaple, bone plate, interbody fusion device, interbody spacer, spinalanchor, intravertebral fusion device, bone clamp, or other anchor.

In one embodiment, one or more of bone anchors 300, 301, and/or 320 isformed such that stem 303 and/or 321 functions as a sheath, defining aninternal chamber 308 and 323 respectively for containing a curablematerial. As illustrated in FIG. 3, internal chamber 308 extends alongstem 303 from proximal head 305 to distal tip 302. As illustrated inFIG. 4, internal chamber 323 extends along stem 321 from proximal head322 to distal tip 324. In a first configuration, when the curablematerial has not been exposed to an energy source, and for a period oftime after exposure, stems 303 and 321 remain flexible to facilitateengagement of the stems within a prepared passageway or to allow angularadjustment along the axis of the stems to better facilitate connectionwith spinal rod 400 or other implant devices prior to completion ofcuring.

In alternative embodiments depicted in FIG. 5, heads 305 or 322 mayinclude an internal chamber 325 with curable material to betterfacilitate connection of spinal rod 400 or other devices thereto eithersingly, or in combination with stems 303 and 321 including internalchambers 308 and 323 respectively. For example, arms 307 could be bentaround the rod when flexible and then hardened to rigidly engage the rodin the passage between arms 307. Furthermore, it is contemplated thatonly a section of stem 303 and/or 321 may include an internal chamberwith curable material to control flexibility of the respective anchordevice 300, 301, and/or 320.

In yet another embodiment, depicted in FIG. 6, stem portion 341 isprovided in an un-formed, malleable configuration that, upon insertioninto a pre-formed cavity 360 in a bony portion 365, stem portion 341conforms to the shape of cavity 360. After application of an appropriatedose of initiating energy and insertion of stem portion 341 into cavity360, as depicted in FIG. 7, hardening of the curable material containedwithin the internal cavity 343 causes anchor 340 to durably engage bonyportion 365.

Spinal rod 400 of implant system 200 is illustrated in FIG. 8. Spinalrod 400 generally includes elongated body 401 extending alonglongitudinal axis L between first end 402 and second end 403. The lengthL1 of spinal rod 400 extending between first end 402 and second end 403is typically great enough to span a distance between at least adjacentvertebral bodies, but in alternative embodiments may have a length L1sized to span a distance between more or less than two vertebral bodies.As illustrated, spinal rod 400 contains a substantially circular orround sectional profile. It is contemplated however that the sectionalprofile of spinal rod 400 may vary in alternative embodiments. Forexample, the sectional profile of spinal rod 400 may include, but is notlimited to, triangular, rectangular, hexagonal, octagonal, oval, or starshaped just to name a few possibilities.

Spinal rod 400 is sized and structured to engage with a receivingportion of a bone anchor, for example, receiving channel 306 of boneanchor devices 300, 301, 320 discussed above. When placed in receivingchannel 306, spinal rod 400 may be coupled thereto create a rigidconstruct between two or more bone anchor devices. Spinal rod 400 mayalso be passively secured to a bone anchor to permit relative motionbetween the bone anchor and spinal rod 400.

In FIG. 8 spinal rod 400 includes internal chamber 404 extending along asubstantial portion of the length L1 of rod 400. Internal chamber 404 isenclosed at least in part by sheath 409, which may comprise all or aportion of body 401, and houses curable material 411. In the embodimentillustrated, in a first configuration when curable material 411 has notbeen exposed to an energy source, and for a period of time afterexposure, spinal rod 400 remains flexible along a substantial portion oflength L1. In a second configuration, after passage of the working timefollowing exposure to a cure-initiating energy, curable material 411hardens and spinal rod 400 becomes more rigid or rigid along length L1.

While internal chamber 404 is shown extending along a substantialportion of length L1 of body 401, it should be understood that inalternative embodiments not shown internal chamber 404 may extend alongonly a portion of length L1. Furthermore, it is contemplated that body401 may include more than one internal chamber 404 such that spinal rod400 includes more than one flexible portion while in an initialconfiguration. In the embodiments where spinal rod 400 includes morethan one flexible portion or where internal chamber 404 only extendsalong a portion of length L1, the remaining section or sections maycomprise any suitable biocompatible material including, but not limitedto, stainless steel, nitinol, chrome cobalt, titanium and alloysthereof, and polymers. In addition, the structure of the remainingsections of spinal rod 400 may be solid or include cannulations orpassages to receive tethers, wires, or cables.

Referring now to FIG. 9 there is shown a cross sectional view of spinalrod 400 viewed along view line 9-9 of FIG. 8. As illustrated, thesectional profile of spinal rod 400 is substantially circular and sheath409 sealingly encloses curable material 411 to prevent leakage ofcurable material 411. Curable material 411 is structured to have aninitial fluid configuration before exposure to an initiating energy andto transform to a rigid form subsequent to exposure to an energy sourceand a cure period. As used herein, the term “fluid” is intended to referto a form that imparts a malleable or flexible characteristic to spinalrod 400. The application contemplates that certain solid forms, such as,for example, particulate solids or otherwise deformable solids canimpart such characteristics to the device, and are therefore includedwithin the meaning of the term “fluid.” The amount of time required fortransition from the flexible configuration to the rigid configurationwill be dependent upon the type of material comprising curable material411. Once in a cured state, the material is structured to providesupport for all or part of a respective implant.

Spinal implant system 200 may further include crosslink device 500,shown in side elevation view with some features in phantom in FIG. 10.Crosslink device 500 includes a first branch member 502 and a secondbranch member 507 connected at an interconnection device 501.Interconnection device 501 may be structured to facilitate translationand/or rotation of branch members 502 and/or 507 relative tointerconnection device 501 and/or each other. Alternatively, branchmembers 502 and/or 507 can be formed integrally as a single unit withinterconnection device 501 or with one another. Branch member 502includes a body 503 between first end 504 and second end 505. Body 503includes internal chamber 506 enclosed by body 503 that functions as asheath, and a curable material can be contained within internal chamber506. Branch member 507 includes first end 509 opposite second end 510with body 508 extending therebetween. Body 508 includes internal chamber511 that functions as a sheath and contains a curable material.

Each of branch members 502 and 507 includes an engagement portion 512and 513, respectively, adjacent ends 504, 509. Engagement portions 512and 513 can be sized and structured to engage with other components ofspinal implant system 200. For example, system 200 may include more thanone spinal rod 400 connected to an additional set of bone screws 300 and301, wherein each of spinal rods 400 extend parallel to each other alongthe spinal column of a patient. In this embodiment, engagement portions512 and 513 engage with each of the spinal rods 400 such that crosslinkdevice 500 extends transversely therebetween. In alternativeembodiments, engagement portions 512 and 513 may be structured to engagewith a bone hook, bone screw, or other anchoring device to which thespinal rod is coupled.

As illustrated, internal chambers 506 and 511 extend substantially alongall the length of the respective branch members 502 and 507. Crosslinkdevice 500 can remain flexible to facilitate interconnection ofcrosslink device 500 with various spinal components before the curablematerial hardens and rigidizes branch members 502 and 507 to create arigid construct between crosslink device 500 and the respective implantcomponents. In alternative embodiments not shown, internal chamber 506and/or 511 may extend along only a portion of branch members 502 and/or507 respectively. Additionally, it is contemplated that each of branchmembers 502 and/or 507 may include more than one internal chamber withcurable material, and that the sheath may form all or a portion of thebranch members 502, 507.

In FIG. 11, there is shown in plan view an alternative elongate spinalfixation element 600 with some features in phantom. Fixation element 600is in the form of a spinal plate and includes a first end portion 601opposite a second end portion 602 and includes a body 603 extendingtherebetween. Fixation element 600 is generally sized and structured toextend between at least one set of adjacent vertebral bodies, but inalternative embodiments may be structured to extend across three or morevertebrae and along one or more regions of the spinal column includingthe cervical, thoracic, lumbar and sacral regions. Fixation element 600includes apertures 604 extending through end portions 601 and 602.Apertures 604 are sized and structured to permit passage of an anchoringdevice, such as a bone screw, to engage with a respective vertebral bodyso that fixation element 600 may be secured thereto. Furthermore, theexterior of fixation element 600 may include one or more surfacefeatures to further promote engagement with a bony structure includingintradiscal projections and fusion members, ridges and valleys, and/or aporous material.

With further reference to FIGS. 12 and 13, fixation element 600 includessheath 610 and curable material 620 contained therein. In a firstconfiguration, body 603 of fixation element 600 remains flexible tofacilitate bending and contouring to the spinal anatomy and/or deliveryto the implant site through a conduit, such as, for example, through adeployment catheter. For example, among other configurations, fixationelement 600 may be bent, twisted, rolled, flattened, elongated, and/orwidened in order to facilitate delivery in a minimally invasive manneror to conform to the environmental characteristics of a desired implantlocation. After passage of the working time following exposure of thecurable material to an energy source, fixation element 600 may becomerigid in the desired formation.

In alternative embodiments not shown, it is contemplated that one ormore sections of plate 600 can be internally partitioned from oneanother such that different materials can be contained therein. Forexample, one or more of end portions 601 or 602 may comprise an internalchamber with curable material while body 603 extending therebetweencomprises a different biocompatible material such that end portion 601and/or 602 is flexible while in an initial configuration while body 603is rigid or may be permanently flexible. Additionally, it iscontemplated that body 603, either singly or in combination with endportion 601 and/or 602, may include an internal chamber with curablematerial while the other portion(s) comprise(s) a different materialsuch that body 603 is flexible in an initial configuration while one orboth of end portions 601 or 602 is rigid or permanently flexible.

With reference to FIG. 14, a device can also be used in connection withan intradiscal spinal implant. FIG. 14 shows one example of anorthopedic device and is generally directed to an intradiscal spinalimplant 700 relative to the spinal column SC of a patient. Implant 700may be used for treatment of several spinal deformities, including, butnot limited to, treatment of degenerative spondylolisthesis, fracture,dislocation, scoliosis, kyphosis, spinal tumor, and/or a failed previousfusion. In the illustrated embodiment, implant 700 is disposed between afirst vertebral body 20 and a second vertebral body 22, with eachvertebral body including an endplate 24, 26, respectively and whereinendplates 24 and 26 are oriented toward one another. The space betweenendplates 24, 26 can be formed by removal or all or a portion of a discspace. Additionally, implant 700 can be employed in corpectomyprocedures where one or more vertebrae are removed.

Implant 700 includes a first vertebral engaging surface 702 and a secondvertebral engaging surface 704 disposed on opposite sides of body 701,wherein each surface 702, 704 is structured to engage an adjacent one ofthe endplates 24, 26 respectively. Surfaces 702 and 704 are depicted asrelatively smooth, but may include alternative surface features inspecific embodiments to facilitate engagement with endplates 24 and 26.For example, the structure of surfaces 702 and 704 may be porous and/orinclude ridges, valleys, spikes, knurling, and/or other securingstructures as would be appreciated by one having ordinary skill in theart.

FIG. 15 is a sectional view of implant 700 along view line 15-15 in FIG.14. Spinal implant 700 includes a sheath 709 about all or a portion ofbody 701 that forms an internal chamber 710 which contains a curablematerial 711. Curable material 711 is in communication with sheath 709and is sealed in the chamber 710 so that it cannot leak or flow from outof sheath 709 and/or body 701. However, the provision of one or moreports that are resealable to selectively allow flow of curable material711 therethrough is not precluded. Each of sheath 709 and curablematerial 711 is generally structured such that implant 700 has aninitial flexible, bendable or formable configuration. However, aftercurable material 711 is exposed to an initiating energy, and following aworking time, it hardens, or rigidizes, and creates a rigid implant.

The implant devices in FIGS. 16-19 are alternative examples ofintradiscal implant devices that may be used for treatment of the spinaldeformities as listed above in regard to spinal implant 700. Implant 720is shown in a perspective view in FIG. 16. Implant 720 can be sized andshaped to occupy all or substantially all of a spinal disc space and canbe implanted in an anterior, antero-lateral or lateral procedure.Implant 720 includes a first vertebral engaging surface 721 opposite asecond vertebral engaging surface 722 and a body 723. Each of surfaces721 and 722 are structured to engage the endplate of a vertebral body,for example, endplates 24 and 26 in FIG. 14. As such, each of surfaces721 and 722 may include securing features such as ridges, valleys,teeth, knurling, and/or other projections or engagement structure. As isknown in the art, surfaces 721 and 722 may comprise a porous material tofacilitate ingress and egress of tissues to further secure implant 720at a spinal location and/or to create fusion of adjacent vertebralbodies.

Implant 720 further comprises an opening 724 extending through body 723from surface 721 to surface 722. In one embodiment, opening 724 maycontain one or more biocompatible materials. In another embodiment,opening 724 contains a bioresorbable material such as a bone growthpromoting material including, but not limited to, a bone graft material,a bone morphogenic protein (BMP), bone chips, bone marrow, ademineralized bone matrix (DBM), mesenchymal stem cells, and/or a LIMmineralization protein (LMP) or any other suitable bone growth promotingmaterial or substance.

In the illustrated embodiment, the entire body 723 surrounding opening724 includes sheath 729 defining internal chamber 725 containing acurable material such as curable material 711 discussed above. When thecurable material has not been exposed to an energy source, and for aworking time following exposure, it allows spinal implant 720 to bereconfigured to a multitude of different configurations by compressionor expansion of implant 720 in a multitude of different directions, asindicated by directional arrows B. For example, among otherconfigurations, all or part of either of surfaces 721 and 722 may becurved to seat against a wholly or partially curved spinal endplate, orthe height H of the spinal implant 720 may be altered to fill a spacebetween intervertebral bodies.

It should be understood that in alternative embodiments not shown only asection or sections of body 723 may contain internal chamber 725 withcurable material in order to provide flexibility at certain locations.In these embodiments, the remainder of implant 720 not includinginternal chamber 725 with curable material may comprise any suitablebiocompatible material as would be recognized by one having skill in theart. Additionally, in another embodiment not shown, it is contemplatedthat only a portion or portions of height H between surface 721 andsurface 722 will include internal chamber 725 and curable material suchthat body 723 takes on a multi-planar configuration, with certain planescomprising curable material 711 while the remaining planes comprise anysuitable biocompatible material that is the same as or that is differentfrom the material of sheath 729. In each of the embodimentscontemplated, the curable material may be exposed to an energy source tocreate a rigid spinal implant 720 of a desired configured formation.

Referring now to FIG. 17, there is illustrated an intradiscalarticulating spinal implant 740. Implant 740 includes a firstarticulating section 741. Section 741 includes an articulating member742 attached to inner surface 745 of a first mounting plate 743. Implant740 also includes a second articulating section 746 including anarticulating member 747 attached to inner surface 750 of a secondmounting plate 748. Each of mounting plates 743 and 748 includes avertebral engaging surface 744 and 749, respectively. Engaging surfaces744 and 749 may include one or more bone engagement structures 744 a,749 a such as keels as shown. Other bone engagement structures arecontemplated including, but not limited to, ridges, valleys, teeth,knurling, and/or other projections or engagement structure(s). It isfurther contemplated that engaging surfaces 744 and 749 may be porous topromote bone and/or tissue ingrowth into mounting plates 743 and 748 aswould be appreciated by one having skill in the art. In anotherembodiment not shown, mounting plates 743 and 748 may include one ormore flanges and/or apertures extending therethrough, wherein theapertures are structured to permit passage of an anchor, including butnot limited to, screws, hooks, staples, and/or sutures, to secureimplant 740 to each of the respective adjacent vertebral bodies. Itshould be understood that the addition of apertures and anchor devicesmay be used alone or in combination with any of the above listed boneengaging structures.

Articulating section 741 and articulating section 746 are structured toengage with one another at interface 751 such that mounting plates 743and 748 are movable relative to one another. As one having skill in theart would recognize, when implant 740 is implanted into anintervertebral space the articulation between sections 741 and 746creates a spinal disc-like motion, and as such, implant 740 may be usedfor disc replacement, among other applications. In the illustratedembodiment, articulating sections 741, 746 are arranged in aball-and-socket type arrangement. Other embodiments contemplate otherarrangements, including resiliently compressible members betweenmounting plates 743, 748, spring elements between plates 743, 748, orother suitable motion preserving structures.

In the embodiment illustrated, each of first mounting plate 743,articulating member 742, articulating member 747, and second mountingplate 748 is formed of material that houses respective ones of theinternal chambers 752, 753, 754, and 755. Each of internal chambers752-755 further includes a curable material such as curable material 711such that the implant 740 has an initial flexible configuration providedby the curable material 711 and the structure of the sheath material. Inanother embodiment, only one of articulating sections 741 or 746 mayinclude one or both of the internal chambers 752 and 753 or 754 and 755and the associated curable material therein. Still, in anotherembodiment, one or more of the portions comprising articulating sections741 and 746 may include its respective internal chamber and curablematerial 711. For example, one or more of mounting plates 743 and 748may include internal chamber 752 or 755 and curable material such thatone or more of mounting plates 743 and 748 may be configured to matinglyengage with the natural or formed surface characteristics of an adjacentvertebral endplate. In another example, one or more of articulatingmembers 742 and 747 includes curable material within the respectiveinternal chamber 753 or 754 such that the one or more of articulatingmembers 742 and 747 is configurable, for example, to change the distanceDD between mounting plates 743 and 748 to facilitate insertion into theintradiscal space. It is further contemplated that any of thearticulating members 742 and 747 and any of the mounting plates 743 and748 may include the flexible configuration singly or in combination withany of the other implant components. In each of the embodimentscontemplated, the curable material may be exposed to an energy sourceprior to insertion into a desired in vivo location to create a rigidspinal implant 740 of a desired conformation after a working time.

An implant 760 for a posterior-lateral or posterior interbody fusionprocedure is illustrated in a perspective view in FIG. 18. Implant 760may be used alone or in combination with one or more other implants in aspinal disc space. Implant 760 includes a width to accommodate insertionthrough a portal created posteriorly or postero-laterally, and can beelongated for orientation in the anterior-posterior directions in thedisc space. Other arrangements contemplate implantation in orientationsobliquely oriented to the sagittal plane or transversely to the sagittalplane in a transforaminal placement. Alternatively, implant 760 can beimplanted anteriorly in side-by-side relation with another implant 760in an anterior fusion procedure.

Spinal implant 760 includes an elongate body 763 extending between afirst end 764 and a second end 765. While body 763 is shown having asubstantially elongated rectangular shape and a correspondingrectangular cross section, it is contemplated that other cross sectionshapes are suitable, for example, including but not limited to, asubstantially circular, triangular, hexagonal, or octagonal shape. Theupper and lower surfaces can be convexly curved to the endplate anatomy.One or more of the sidewalls can include a concave shape or convexshape. In an embodiment not shown, spinal implant 760 may includeexternal threading extending along all or part of body 763 between ends764 and 765 to provided threaded engagement between adjacent vertebralbodies. Implant 760 may include other engagement structures along all ora portion of its outer surfaces, including porous structures, ridges,grooves, teeth, and/or other projections, all of which are structured toimprove implant holding power and/or fusion at the implant site.

As illustrated, body 763 of spinal implant 760 forms a sheath thatdefines internal chamber 766, which contains a curable material thereinextending along substantially all of body 763. When internal chamber 766with curable material extends along substantially all of body 763,implant 760 can be configurable in multiple directions as indicated bydirectional arrows C to change its shape length, width and/or height toaccommodate an implantation site or insertion portal. In anotherembodiment not shown, body 763 defines an internal chamber with curablematerial that extends along only a section of body 763. The portion ofbody 763 along the internal chamber is formed at least in part by asheath, and the remainder of body 763 can be formed by any suitablebiocompatible material. In certain embodiments, body 763 may include atleast one cavity structured to contain a bone growth inducing agent suchas, but not limited to, a bone graft material, a bone morphogenicprotein (BMP), bone chips, bone marrow, a demineralized bone matrix(DBM), mesenchymal stem cells, and/or a LIM mineralization protein (LMP)or any other suitable bone growth promoting material or substance. Ineach of the embodiments contemplated for implant 760, the curablematerial in the chamber may be exposed to an energy source to create arigid spinal implant 760 of a desired configured formation.

FIG. 19 is a perspective view of an intradiscal implant 770 that can beused for either partial or entire replacement of the nucleus pulposus tofacilitate augmentation of the annulus fibrosis. Implant 770 includes abody 771 that forms a sheath which surrounds and creates internalchamber 772 to contain curable material therein. In this embodiment,implant 770 is configurable in multiple directions, as indicated by, forexample, directional arrows E, which indicate height and radialadjustability of body 771 to better fit an implant site. In anotherembodiment not shown, implant 770 may include internal chamber 772 inonly a selected portion or portions of body 771. Additionally, asillustrated, implant 770 can have a substantially cylindrical shape, butit should be understand that alternative shapes and structures forimplant 770 are contemplated. For example, the size, height, and shapeof implant 770 may be changed to better conform to the shape of acorrespondingly prepared implant site, natural anatomic features, orinsertion portal of particular size and shape. In each of theembodiments contemplated, the curable material may be exposed to anenergy source prior to insertion into a desired in vivo location tocreate a rigid spinal implant 770 of a desired conformation after aworking time.

Another aspect of the application is depicted in FIG. 20, in whichdevice 800 includes biocompatible sheath 810 and curable material 820contained and sealed in sheath 810. Curable material 820 has a non-rigidform, and is transformable to a rigid form after a working time thatfollows application of a quantity of an initiating energy to material820 that is effective to cure material 820. Device 800 is deformablebefore and during implantation within a patient, and can be configuredin a wide variety of shapes and sizes for a wide variety of end usesafter curing of the curable material. Device 800 also includespressurizeable balloon 840 contained within sheath 810 such that curablematerial 820 is positioned outside balloon 840. When a pressurizingfluid is introduced into balloon 840 through port 850 under sufficientpressure, balloon 840 is pressurized and exerts an outward pressure oncurable material 820 and sheath 810. The outward pressure canadvantageously result in sheath 810 being pressed against adjacentstructures, such as, for example, adjacent bony portions or adjacentimplant components, to cause the device to more properly engage sameand/or mate therewith. The curable material then hardens as a result ofits exposure to an initiating energy prior to insertion, to create arigid implant of a desired configured formation. As used herein, theterm “balloon” is used to refer to a thin, flexible container that canbe filled with a liquid or gas under pressure to expand the balloon,thereby exerting a pressure on and expanding the curable material andsheath in which it is contained.

A balloon selected for use can be constructed in a variety of ways,including using techniques that are know to be effective for makingballoons for balloon angioplasty applications, and suitable materialsfor preparing balloons may include those that are presently used forsuch purposes as balloon angioplasty. Desirable materials provide anoptimal combination of such properties as compliance, biostability andbiocompatability, and mechanical characteristics such as elasticity andstrength. Balloons can be provided in a variety of suitable forms,including those having a plurality of layers and those having aplurality of compartments when expanded. A useful balloon apparatus willinclude the balloon itself, together with a fluid or gas pressureapplying means.

Examples of suitable materials for making balloons include, but are notlimited to, polyolefin copolymers, polyethylene, polycarbonate,polyethylene terephthalate and ether-ketone polymers such aspoly(etheretherketone). Such polymeric materials can be used in eitherunsupported form, or in supported form, e.g., by the integration ofDacron™ or other fibers. In addition, the balloon (or balloon-likestructure) may comprise a wide variety of woven or nonwoven fibers,fabrics, metal mesh such as woven or braided wires, and carbon.Biocompatible fabrics or sheet material such as ePTFE and Dacron™ mayalso be used. In some embodiments, the balloon has metallic wires orother imageable means incorporated into it. Any material that can beseen under fluoroscopy would be acceptable. Potential materials includeany metal, metal alloys, or ceramics that could be combined with apolymer. The material can be in the form of wires, a mesh, or particlesincorporated into the balloon or on its surface.

Further details regarding certain exemplary embodiments that includeballoons are provided herein with reference to FIGS. 21-23. In theembodiment depicted in FIG. 21, bone anchor device 900 includes stemportion 903 that is provided in a malleable configuration and thatincludes sheath 910, defining an internal chamber for containing curablematerial 920. Internal chamber, and thus curable material 920, extendsalong stem 903 from proximal head 905 to distal tip 902. In a firstconfiguration, when the curable material has not been exposed to anenergy source, and for a working time following exposure, stem 903remains flexible to facilitate engagement of stem 903 within a preparedpassageway such as pre-formed cavity 960 in bony portion 965, or toallow angular adjustment along the axis of the stem to better facilitateconnection with another structural component, such as, for example,spinal rod 400. Bone anchor device 900 also includes pressurizeableballoon 940 contained with sheath 910 such that curable material 920 ispositioned outside balloon 940. When a pressurizing fluid, such as, forexample, saline, is introduced into balloon 940 through port 950 undersufficient pressure, balloon 940 is pressurized and exerts an outwardpressure on curable material 920 and sheath 910. Thus, when balloon 940is pressurized after stem 903 is positioned within cavity 960, as shownin FIG. 22, stem 903 is caused to conform to the shape of cavity 960, asdepicted in FIG. 23. When stem 903 has a desired conformation, hardeningof the curable material 920 causes anchor 900 to durably engage bonyportion 965.

In the embodiment depicted in FIG. 24, spinal rod 1000 includes sheath1010, defining an internal chamber for containing curable material 1020.Internal chamber, and thus curable material 1020, extends along rod 1000from first end 1002 to second end 1003. In a first configuration, whenthe curable material has not been exposed to an initiating energysource, rod 1000 remains flexible to facilitate engagement of rod 1000with other implant components, such as, for example, to allow angularadjustment along the axis of the rod to better facilitate connectionwith another structural component, such as, for example, a bone anchoror a crosslink device. Spinal rod 1000 also includes pressurizeableballoon 1040 contained with sheath 1010 such that curable material 1020is positioned outside balloon 1040. When a pressurizing fluid, such as,for example, saline, is introduced into balloon 1040 through port 1050under sufficient pressure, balloon 1040 is pressurized and exerts anoutward pressure on curable material 1020 and sheath 1010. Thus, whenballoon 1040 is pressurized, rod 1000 is caused to conform generally tothe shape of adjacent structures (not shown) and/or to engage or form aninterference fit with adjacent structures, such as, for example, one ormore bone anchors or crosslink devices. When rod 1000 has a desiredconformation, hardening of the curable material 1020 causes rod 100 torigidize, and provide a load-bearing function. Pressurizing balloons,such as balloons 840, 940 and 1040, can be used in connection with awide variety of other embodiments, such as, for example, in spinaldevices for other intradiscal and extradiscal devices including but notlimited to devices operable to movably support the vertebrae andinterbody fusion devices.

In FIG. 25, spinal rod 1100, depicted in cross-section, includesreinforcement member 1170 contained within sheath 1110 and embedded incurable material 1120. In the embodiment shown, reinforcement member1170 comprises a structural matrix material composed of multiple fiberssuch as, for example, a matrix of carbon fibers. Alternatively, a widevariety of alternative materials and architectures can be employed forreinforcement member 1170 as would be contemplated by a person ofordinary skill in the art. For example, reinforcement member 1170 maycomprise, but is not limited to, fused silica, metal or ceramicparticles, PET fibers, PET mesh, and/or carbon fibers, just to name afew. Reinforcement member 1170 is structured to provide additionalimplant support to increase implant rigidity and strength when necessaryto achieve a desired compression or other force at an implant site.While reinforcement member 1170 is shown within spinal rod 1100, itshould be further appreciated that reinforcement member 1170 may beincluded in the other implants described and contemplated herein.

Because light and other electromagnetic radiation, and thermal energy,have limits with regard to the depth to which they can penetrate forinitiating curing reactions, particularly in embodiments in which thesheath and/or the curing material is not transparent or translucent tothe radiation wavelength or not good thermal conductors (in the case ofa heat-initiated curable material) the application also provides devicesthat include internal elements for delivery of the initiating energy tothe curable material.

In the embodiment depicted in FIG. 26, device 1200 includes internalenergy delivery element 1280 contained within sheath 1210 and adjacentcurable material 1220. Device 1200 also includes connector 1282 forconnecting energy delivery element 1280 to an external energy source(not shown). In alternate embodiments, energy delivery element 1280 canbe a heating element, a fiber optic element, an antenna, an electricalelement, or an element for delivering other forms of energy. Of course,the type of energy delivery element selected for use in a givenembodiment will depend upon the curable material selected for use, thetype of energy necessary to initiate curing of same, and the quantity ofenergy necessary to achieve the desired degree of curing.

In one embodiment, energy delivery element 1280 is a heat deliveryelement. Heat delivery elements suitable for use can comprise a varietyof forms. For example, in one embodiment, the heat delivery element is aconduit formed as a loop for circulating heated media therethrough todeliver heat to the curable material, thereby initiate curing of thecurable material. Of course, to deliver the thermal energy to thecurable material in this embodiment, it is necessary to connect a sourceof heated media to one end of the loop, and to connect a drain to theother end of the loop for removing the media from the location of theimplant after passage thereof through the device. Alternatively, theloop can be connection to a heated pump that forms a closed circuit withthe loop, thereby reheating and re-circulating the medium forintroduction back into the loop.

Another example of a heat delivery element that can be used is aresistive heating element, such as, for example, a coated tungsten wireor carbon fibers. In this embodiment, because the resistive heatingelement operates only upon the passage of electrical currenttherethrough, the heating element is oriented in a manner whereby theelement forms a continuous electrical pathway. In various embodiments,the resistive heating element may be made from material with either apositive or negative temperature coefficient of resistance, e.g.,electrical resistance either directly or indirectly proportionate totemperature, respectively. The temperature may be monitored by measuringthe DC voltage across the resistive heating element, for the voltage isdirectly proportional to resistance for a given current, and thetemperature coefficient of resistance is known. Alternatively, bymeasuring the voltage, current and phase of the drive system, theresistance of the heating element and thus its temperature can becalculated, optionally by a microprocessor or dedicated circuitry.

In order to deliver heat using a resistive heating element, it isnecessary to operably connect a source of electrical current to energydelivery element 1280 via connector 1282, and pass current therethroughfor a period of time sufficient to deliver a desired quantity ofinitiating thermal energy to curable material 1220. The source can be,for example, a battery (not shown) or an AC/DC converter. Connector 1282and element 1280 in FIG. 26 are intended to schematically represent notonly embodiments in which energy is simply introduced into energydelivery element 1280, such as, for example, by passing light intoelement 1280, but also embodiments that require multiple energy conduitsand looped energy delivery elements, where appropriate. In this regard,in an embodiment that utilizes electrical current to provide heat or toprovide electrical energy directly to the curable material, connector1282 can comprise multiple electrical contacts for conducting a currentthrough element 1280. For example, electrical contacts can include aconcentric sliding fit connection for linking connector 1282 to a sourceof electrical power (not shown). These electrical contacts engagecomplimentary contacts on the electricity source to complete an electriccircuit with a proximally located power supply for actuating theresistive heating element. Another manner of achieving multipleconnections for achieving looped circuitry or other types of loopedconduits, is by including optional second connector 1283. In thisregard, device 1200 can include multiple connectors 1282, 1283 toprovide an energy delivery circuit by connecting both connectors toseparate leads from an electrical source, thereby providing anelectrical circuit through device 1200.

When heat curing is used, it is preferred that the temperature of theoutside of the device at the time of implant not be so high that itcauses localized tissue necrosis, which occurs at approximately 45° C.This may be accomplished in several ways, such as, for example, byutilizing a heat source that sets up a temperature differential betweenthe surface of the implant and the interior of the implant, or byutilizing a sheath 1210 composed of materials and/or having a thicknessto provide thermal insulation of the adjacent tissue from heat generatedby the heating element. Depending upon the make-up of the curablematerial 1120 selected for use, in some embodiments it is desirable touse a sheath that is composed of an electrically insulative material.

In some instances, the hardenable material is simply a material (such asa low temperature polymer) having a melting point (for crystallinematerials) or a glass transition temperature (for amorphous materials)marginally above body temperature (37° C.), and is therefore solid atbody temperature. In one embodiment, the melting point or glasstransition temperature is between about 37° C. and about 100° C. Inanother embodiment, the melting point or glass transition temperature isbetween about 37° C. and about 75° C. In yet another embodiment, themelting point or glass transition temperature is between about 37° C.and about 50° C. In some embodiments, these low temperature materialsare simply heated to the point where they are viscous and flowable andthen placed at the desired location in the desired position so that thesubsequent cooling of the viscous material to body temperaturesolidifies the device. In other embodiments, solidification of thedevice can be hastened by passing a cooling medium through a loop insidethe device in a manner similar to that described above in connectionwith embodiments that utilize a heated medium. Because these materialsdo not need to react in vivo, they are desirable for their relativeinertness.

In other alternative embodiments, the heat delivery element can comprisean RF antenna, an ultrasound transducer, a microwave antenna or awaveguide capable of converting these respective forms of energy to heatenergy for delivery to the curable material. A person skilled in the artwill also appreciate that, if a reinforcement member, such asreinforcement member 1170, is included in the device that is made froman electrically conductive material or a material suitable for use as anRF antenna, an ultrasound transducer, a microwave antenna or awaveguide, the reinforcement member can be utilized both to provide areinforcement function and also to operate as a heating element.

In another embodiment, curable material 1220 is a photocurable material,and energy delivery element 1280 is a light delivery element. As usedherein, the term “photocurable” is intended to refer to a material ofthe type for which the application of electromagnetic energy at awavelength within the visible light spectrum initiates curing. In suchan embodiment, the energy delivery element can be a fiber optic element,or can be composed of other material that effectively transmits light.In one embodiment, internal element 1280 is a transparent or translucentconduit defining an open cavity (i.e., for temporary insertion of alight source). In another embodiment, sheath 1210 has an internalsurface 1212, oriented toward curable material 1220, that is effectiveto reflect at least a portion of the light emitted by element 1280.

In an embodiment that utilizes light energy to initiate cure, the lightcan be delivered to the energy delivery element in a variety of ways.For example, the light can be provided by simply shining light from ahand held light emitter onto an exposed portal capable of delivering thelight into the energy delivery element, such as, for example, a fiberoptic cable. Alternatively, light can be delivered to the element byphysically connecting a light source to the element. In otherembodiments, curable material 1220 is of the type for which theapplication of electromagnetic energy at a wavelength outside thevisible light spectrum initiates curing. In this embodiment, energydelivery element 1280 comprises an electromagnetic radiation deliveryelement. In another embodiment, sheath 1210 has an internal surface1212, oriented toward curable material 1220, that is effective toreflect at least a portion of the electromagnetic radiation. In variousembodiments, the electromagnetic radiation is, by way of non-limitingexample, radio frequency radiation, x-ray radiation, infrared radiation,ultraviolet radiation and microwave radiation.

A device can also include multiple energy delivery elements within asingle sheath, for example as shown in FIGS. 27 and 28. In FIG. 27,device 1300 includes two energy delivery elements 1380 a and 1380 blinked to connector 1382 for connection to an external energy source(not shown). Optional connector 1383 can also be included, and isparticularly useful in embodiments in which it is desirable to includeone or more of elements 1380 a and 1380 b in a loop or circuit, such asan electrical circuit or a heated media circulation loop, as describedabove. In FIG. 28, device 1400 includes two energy delivery elements1480 a and 1480 b, each of which is linked to its own connector 1482 aand 1482 b, respectively. Optional connectors 1483 a and 1483 b can alsobe included, and are particularly useful in embodiments in which it isdesirable to include one or more of elements 1480 a and 1480 b in a loopor circuit, such as an electrical circuit or a heated media circulationloop, as described above. Of course, other numbers of energy deliveryelements contained in a single sheath can be employed, and anycombination of connectors can be used that is suitable for delivering anappropriate quantity of energy to the curable material at a desiredrate.

The application contemplates that the energy delivery element can takeon a variety of different forms, as would occur to a person of ordinaryskill in the art. For example, it is understood that a more even andthorough initiation of curing can be achieved when less distanceseparates an energy source or an energy delivery element and a curablematerial for which cure-initiation is desired. For example, in a devicethat is relatively thin, no internal energy delivery element isnecessary as long as the sheath is formed to pass the energytherethrough, because the energy can penetrate a certain distance intothe curable material. On the other hand, when a device includes acurable material having larger dimensions, it is desirable to have oneor more energy delivery elements positioned such that no curablematerial exceeds a certain maximum distance from an energy deliveryelement. In one example of a manner to achieve more uniform energydelivery, a device such as device 1500 depicted in FIG. 29 includes anenergy delivery element 1580 having a plurality of appendages 1581 fordelivery of energy to peripheral portions of curable material 1520 frompoints nearer to the curable material. In another embodiment, depictedin FIG. 30, device 1600 includes a coil-shaped energy delivery element1680. In yet another embodiment, energy delivery component 1780 depictedin FIG. 31 has a flexible zig-zag pattern. Of course, a wide variety ofalternative configurations can be used in other embodiments.

The application also contemplates devices that include energy deliveryelements of different types contained within the same sheath, such as,for example, one or more energy delivery elements for delivering visiblelight and one or more other energy delivery elements for deliveringheat. In this regard, the application contemplates systems in which thecurable material contained within a sheath of a given device includes amixture of compositions for which curing is initiated by different typesof energy. In other embodiments, curable materials that are initiated bydifferent types of energy can be contained within separated compartmentswith a sheath or within multiple sheaths of a single device. Devices canthus be constructed that have different hardening characteristics due todifferent cure profiles exhibited by different curable materials. Asused herein, the term “cure profile” is intended to refer to acombination of characteristics of the material that affect its curingfeatures, such as, for example and without limitation, the type ofenergy that can be used to initiate curing, the quantity of energy thatis required to initiate curing or to fully cure the material, the rateat which curing proceeds after it is initiated, the effect ofinterruption of energy exposure on curing, the effect that the quantityof energy has on the rate of curing, and the like.

FIG. 32 depicts a device 1800 that includes energy delivery elements1880 a and 1880 b, pressurizeable balloon 1840 and reinforcement member1870 contained within sheath 1810. The application also contemplatesdevices that omit one or more of these components, as discussed herein.For example, the application contemplates a device that includes apressurizeable balloon and reinforcement member but no energy deliveryelement (for example in embodiments in which energy is delivered tocurable material from a point exterior to the device through thesheath). The application also contemplates a device that includes areinforcement member and an energy delivery element but nopressurizeable balloon, and a device that includes a pressurizeableballoon and energy delivery component but no reinforcement member. Ofcourse, the application also contemplates devices including only one ofthese components, as described herein.

A device can be made to have features whereby the device isself-contained, sealed and shelf-stable for a significant period oftime. For example, in one embodiment a device includes asingle-component curable composition that is pre-mixed and sealed withinthe sheath of the device, yet which will not begin curing until theinitiating energy is applied. Such an embodiment, in addition to otherexcellent features, avoids complications that occur during a wet out ora 2-part mixing process during a surgery, as are required in certaincurable systems proposed in the prior art. In addition, such a devicecan be pre-packaged and sterilized so that when medical personnelwithdraw the device from the package, it is immediately ready forapplication of the initiating energy and implantation within a patient.Indeed, the initiating energy can be applied prior to removal of thedevice from the package if desired. In one embodiment, depicted in FIG.33, device 100 is shown contained within package 130. In alternativeembodiments, device 100 is sterilized prior to sealing within package130, or device 100 and package 130 are sterilized together afterplacement of device 100 within package 130. The package can beconfigured to protect the implants from exposure to initiating energybefore an anticipated implant time. The cover may be structured forremoval before implantation or may be removed after placement at an invivo location.

The application also contemplates orthopedic implants that includemultiple components that are malleable and/or flexible at the time ofimplant, and then cured to a rigid form after being positioned at theimplant site. In one embodiment, an implant includes a plurality ofinventive devices that include the same curable material. In anotherembodiment, the respective devices include different curable materials.An implant can be constructed to have different components withdifferent cure profiles, such that a surgeon performing the implantingprocedure can achieve cure of the respective devices in a controlledfashion. For example, in certain circumstances, it might be preferred touse bone-engaging devices that harden before, or more quickly than,non-bone-engaging devices of an implant. In other embodiments, it mightbe preferred to use non-bone-engaging devices that harden before, ormore quickly than, bone-engaging devices.

As will be appreciated by a person skilled in the art, the curablematerial can comprise a wide variety of compositions. In one embodiment,the curable material includes a single component epoxy. In anotherembodiment, the curable material comprises a photocurable material. Inan exemplary embodiment when curable material is photocurable, itcomprises a pre-activated epoxy adhesive with medium viscosity. Onephotocurable material of this nature is commercially available by theHenkel Corporation as Loctite® 3355. Among other attributes, thismaterial has single component construction, curability upon exposure toUV light, fast cure time, and low shrinkage and resistancecharacteristics upon cure. This material also includes low outgasing andwill cure evenly across all regions, even those that are shaded. Thecurable material can be provided in unitary form, e.g. in a form thatneed not be mixed just prior to use. Rather, after positioning thedevice, the curable material is exposed to initiating energy to causepolymerization through intermediation of the catalyst system. Asdescribed above, multiple different curable materials can be used, i.e.,at different layers or portions of the device, so that curing with onetype of initiating energy, such as, for example visible light or othertype of electromagnetic radiation of one wavelength cures a portion ofthe device, and then exposure to another wavelength or another type ofenergy cures another portion. A wide variety of curable materials arecontemplated by the application, and examples of curable materials thatare suitable for use can be found in one or more of U.S. Pat. No.5,837,752 to Shastri, U.S. Pat. No. 6,987,136 to Erbe et al., U.S. Pat.No. 5,681,872 to Erbe, U.S. Patent Application Publication No.2003/0125739 to Bagga et al. and U.S. Patent Application Publication No.2004/0230309 to Di Mauro, each of which is incorporated by referenceherein in its entirety.

It is further contemplated that the devices can be provided in a productkit with fully assembled devices that need only to be exposed toinitiating energy to initiate cure and implanted in to the patientfollowing the exposure. In another form, a product kit is provided wherethe devices are partially assembled or unassembled. In this form, thesurgeon can select the device components for assembly during theprocedure to provide flexibility in selection in the type of device, thesize of the device, and/or the type and amount of curable material withwhich to fill the device.

A method for forming and positioning a load-bearing component of anorthopedic implant device includes providing a self-contained, malleabledevice as described herein, applying a dose of a suitable initiatingenergy to the material and inserting the device to an in vivo locationwhere the provision of load-bearing functionality is desired. If thedevice is provided in a sterilized form in a sealed package, the devicecan be removed from the package in a sterile environment, i.e., in asurgical theater, before or after exposure to cure-initiating energy,and before or after being inserted into the in vivo location.

In one manner of practicing the method, before the device is inserted tothe in vivo location, it is shaped into a compacted configuration fordelivery, for example, by folding or flexing the device. After thedevice is inserted, it can be formed to a desired shape and a desiredorientation relative to a bony portion. For example, the device can bereformed, after insertion to the in vivo location, into an expanded formthat is larger than the compacted form in at least one dimension. In anembodiment in which the device includes a pressurizeable ballooncontained within the sheath, the reforming can include introducing apressurizing fluid, such as, for example, saline or air, into theballoon to pressurize the balloon and exert an outward pressure on thecurable material and the sheath.

In one manner of practicing the method, before the device is inserted toa desired in vivo location and configured to a desired form, the curablematerial is exposed to energy transmitted from a hand held or portableenergy source. Energy may be in more than one form when exposure to thecurable material occurs. For example, energy may be UV light and alsoinclude thermal energy, which might in some embodiments increase therate of cure for the curable material. After a working time followingapplication of a sufficient dose of initiating energy, the curablematerial rigidizes to provide a load-bearing component of an implant.After the initiating energy is applied to the material, the malleablecomponent is inserted to a desired in vivo location and maintained in adesired orientation for a period of time sufficient for the curablematerial to harden, thereby forming a load-bearing component having adesired conformation for engagement with a bony portion or anothercomponent of an orthopedic implant. During the period of time that thecurable material hardens, the surgeon or other medical personnel canoptionally further flex or otherwise form the device to modify itsposition or shape. In this way, flexibility in, and control of, theshape of the device is provided.

In one embodiment, the application of energy comprises exposing thecurable material to the initiating material for a time period of fromabout 1 second to about 30 minutes. In another embodiment, the applyingcomprises exposing the curable material to the initiating energy for atime period of from about 5 seconds to about 5 minutes. It is furthercontemplated that the working time after exposure to the energy canrange, for example, from about one minute to about 60 minutes. Inanother form, the working time is at least about 2 minutes. In yetanother form, the working time is at least about 5 minutes. In stillanother form, the working time is at least about 10 minutes. As usedherein, the term “working time” is intended to refer to the timefollowing application of cure-initiating energy during which the devicecan be worked or manipulated prior to the occurrence of a level ofcuring that increases the modulus to a point where working of the deviceis not feasible or practicable. It should be understood that the cureperiod for the curable material will depend upon the type of materialutilized and, in certain embodiments, the cure period will be dependentupon the exposure time and intensity of energy. Additionally, thenecessary exposure time and intensity of energy to achieve a desireddegree of curing may depend on the properties of the curable material.For example, in an embodiment where the curable material is aphotocurable material, exposure time and intensity may depend on whetherthe curable material is clear or opaque. It should also be appreciatedthat the amount of a device which needs to be exposed, whether in wholeor in part, may also depend on one or both of the composition of thecurable material and the type of energy used.

When curing certain embodiments, the cure-initiating energy is providedto curable material 120 through sheath 110 from a remote source that isnot physically connected to device 100. For example, energy can betransmitted to device 100 from a hand-held transmitter 200, as depictedin FIG. 36. Initiating energy, which can be, for example, light,non-visible electromagnetic radiation or heat, is represented in FIG. 36by arrows 205. In such embodiments, it is important that sheath 110 bestructured to transmit the initiating energy 205 therethrough, and alsothat the curable material 120 have sufficiently small dimensions thatthe energy 205 is able to reach all necessary portions of the curablematerial through the sheath to initiate curing at a desired level. Forexample, as discussed above, in embodiments in which the curablematerial is a photocurable material, the sheath can be composed of atranslucent or transparent material, and the light energy used to curethe material can pass into the curable material to a sufficient degreeto achieve a desired level of curing. In embodiments in which thecurable material is a heat-curable material, the sheath can be composedof a heat transmitting material. When using a device containing aheat-curable material, heat conductive structures (not shown) can bepositioned within the sheath to assist with delivery of heat from thesheath to the innermost portions of curable material in the device. Suchstructures, which operate as energy delivery elements as describedabove, can be, but need not be, in direct contact with the sheath.

In another manner of delivering energy to curable material 120 throughsheath 110, device 100 is placed inside energy source 210, as depictedin FIG. 38. For example, when employing a device that contains aheat-curable material, source 210 can be a heating device such as, forexample, a convection oven. Heat can be provided by source 210 in avariety of ways known in the art, including inductive heating mechanismsor resistive electrical coils, to name a few examples. Alternatively,source 210 can provide light or other form of electromagnetic radiationto device 100 if device 100 includes a photocurable material or amaterial that is curable by exposure to electromagnetic radiationoutside the visible light spectrum. In yet another embodiment, source210 provides mechanical energy, such as, for example, ultrasonic energyto device 100 located therein.

In another embodiment, source 210 includes intensity controller 211 foradjusting the intensity of the energy delivered to device 100 fromsource 210. In another embodiment, source 210 includes timer 212. Timer212 can operate, for example, to turn off energy source 210 at the endof a predetermined amount of time; to activate a signal, such as alight, a bell or a buzzer at the end of a predetermined amount of time;or to change the type or intensity of energy emitted by source 210.

In other embodiments, the initiating energy is introduced into thedevice through one or more connectors that pass through the sheath toone or more energy delivery elements contained within the sheath, asdescribed in detail above and as depicted in FIGS. 34 and 35. Withreference to FIG. 34, delivery of initiating energy to energy deliveryelement 1280 within an in vivo device 1200 can be achieved by connectingenergy delivery leads 1291, 1292 to connectors 1282, 1283 that passthrough the device's sheath 1210. For example, in the case of aresistive heating element or an electricity-delivery element, each ofwhich require the delivery of electrical current, leads 1291, 1292 frompower source 1290 can be connected to the connectors 1282, 1283 in amanner that achieves an appropriate current through the energy deliveryelement 1280 (or multiple elements when more than one is present in thedevice). With reference to FIG. 35, in the case of photo-curableembodiments, light can be provided to device 1200 by connecting energydelivery lead 1296 to connector 1282 that passes through sheath 1210 todeliver light from light source 1295 to energy delivery element 1280,which in this embodiment is a fiber optic element. Of course, additionalleads (not shown) can be used to deliver light to additional elements(not shown, but as shown in connection with other embodiments) when morethan one is present in the device. In other embodiments, source 1270 andsource 1295 include intensity controllers 1293, 1297 for adjusting theintensity of the energy delivered to device 1200 from source 1270, 1295.In another embodiment, source 1270, 1295 includes timer 1294, 1298.Timer 1294, 1298 can operate, for example, to turn off energy source1270, 1295 at the end of a predetermined amount of time; to activate asignal, such as a light, a bell or a buzzer at the end of apredetermined amount of time; or to change the type or intensity ofenergy emitted by source 1270, 1295.

The application also contemplates embodiments in which the sheath iscomposed of a self-sealing material, and curing is initiated byinjecting into the curable material a dose of a chemical initiatoreffective to initiate curing.

Whether delivering light, electricity or other types of energy in therespective embodiments, leads 1291, 1292 or 1296 can be connected to adevice to initiate curing, and the device can then be inserted to an invivo location through a relatively large surgically-created opening, orthrough one or more relatively small openings using endoscopic equipmentor radiologically-guided equipment suitable for use in minimallyinvasive procedures.

When a device including a pressurizeable balloon is used, a load-bearingcomponent of an orthopedic implant device can be formed and positionedby applying a dose of the initiating energy to the material, insertingthe device to an in vivo location where the provision of load-bearingfunctionality is desired, infusing a fluid into the balloon topressurize the balloon, thereby pressurizing the curable material. Ifthe device is provided in a sterilized form in a sealed package, thedevice can be removed from the package in a sterile environment, i.e.,in a surgical theater, before or after application of thecure-initiating energy and before or after being inserted into the invivo location.

This aspect of the application is particularly advantageous inconnection with the placement of a bone anchor. As described above, anexemplary bone anchor device includes a bone engaging portion opposite ahead portion. The bone engaging portion is structured to engage bonytissue, and the head portion is structured to engage an elongate implantcomponent, such as, for example, a spinal rod. In certain embodiments,the head portion is moveable relative to the stem. The sheath can extendalong all or a portion of the bone engaging portion. Because the stem isexpandable, an increased degree of variability can be tolerated in thepreparation of cavities in bony portions to receive the bone anchor.More specifically, it is typically necessary, before positioning a boneanchor, to provide a cavity in a bony portion to receive the stem of theanchor. The exact dimensions of the cavity, and the uniformity of thecavity features, are less critical than would be the case if the anchorswere pre-formed, pre-sized and rigid. Moreover, the cavity need onlyhave at least one anchor-retaining surface to affix an anchor therein.Indeed, as shown in FIG. 37, as long as cavity 960 has an area 961proximal to the surface 966 of bony portion 965 that is narrower than anarea 962 that is more distal to the surface 966 of bony portion 965, ananchor device as provided herein, such as, for example, anchor 900, canbe used to engage bony portion 965 by pressure-fitting stem 903 ofanchor 900 to walls 964 of cavity 960.

Thus, in one embodiment, a cavity is provided in a bony portion toreceive the anchor device, the cavity defining at least oneanchor-retaining surface configured to engage the bone anchor. Afterapplication of initiating energy to the curable material, the stem ofthe anchor device is passed into the cavity, and the balloon ispressurized to pressure-fit the stem to the walls of the cavity.Hardening of the curable material solidifies the engagement between thebone anchor and the bony portion. Embodiments including a pressurizeableballoon are also well suited for use as interbody devices. In thisregard, pressurization of the balloon after placement of the interbodyspinal device in position advantageously allows the device to betterconform to the natural contours of the endplates adjacent thereto, andto spread the load-bearing function more evenly across the surfaces ofthe device and the endplates, which reduces the risk of pressurefractures to adjacent vertebrae.

Pressurization of the balloon can be achieved in a manner similar topressurization of angioplasty balloons known in the art. Pressurizingfluid, such as, for example, saline or air, can be delivered to thedevice by a delivery conduit (not shown) connected to an invivo-positioned device. The conduit can be connected to a port, such as,for example, ports 850, 950 or 1050 in various embodiments, by passageof the conduit through a relatively large surgically-created opening, orthrough a relatively small opening using endoscopic equipment orradiologically-guided equipment suitable for use in minimally invasiveprocedures. It is understood that the conduit and the port will includestructures necessary to achieve a suitable connection for containingpressurized fluids during pressurization of the balloon.

The application also contemplates orthopedic implant devices of whichmultiple components are formed using curable devices described herein.For example, in certain spinal fixation devices, multiple bone anchors,spinal rods and supporting components are commonly included, a pluralityof which can be formed from malleable devices as described herein. Thus,in one aspect of the application, the methods described above canfurther include providing a second curable device, applying a dose ofinitiating energy to the curable material of the second curable deviceand inserting the second curable device to an in vivo location where theprovision of load-bearing functionality is desired. The second curabledevice can exhibit the same curing profile as the first component, orcan optionally exhibit a different curing profile than the firstcomponent.

In another aspect of the application, there is provided an orthopedicimplant kit that includes (1) a device including a biocompatible sheathand a curable material having a non-rigid form contained and sealed inthe sheath, wherein the material is transformable to a rigid form afterapplication of a quantity of an initiating energy to the materialeffective to fully cure the material; and (2) instructions, recorded ina tangible medium, for applying a cure-initiating energy to the curablematerial and then positioning the device in an in vivo location wherethe provision of load-bearing functionality is desired. The instructionscan be customized for application to devices of a wide variety ofdifferent embodiments, and can also include alternate instructions for agiven device, which provides flexibility to the surgeon using thedevice.

While multiple embodiments have been illustrated and described in detailin the drawings and foregoing description, the same is to be consideredillustrative and not restrictive in character, it being understood thatonly selected embodiments have been shown and described and that allchanges, equivalents, and modifications as would occur to those skilledin the art and that come within the scope of the inventions describedherein or defined by the following claims are desired to be protected.Any theory, mechanism of operation, proof, or finding stated herein ismeant to further enhance understanding of the present application and isnot intended to limit the inventions in any way to such theory,mechanism of operation, proof, or finding. In addition, the variousprocedures, techniques, and operations may be altered, rearranged,substituted, deleted, duplicated, or combined as would occur to thoseskilled in the art. Further, any U.S. Patent, pending U.S. PatentApplication Publication or other publication cited herein isincorporated herein by reference in its entirety as if each individualpublication, patent, or patent application was specifically andindividually indicated to be incorporated by reference and set forth inits entirety herein. In reading the claims, words such as the word “a,”the word “an,” the words “at least one,” and the words “at least aportion” are not intended to limit the claims to only one item unlessspecifically stated to the contrary. Further, when the language “atleast a portion” and/or “a portion” is used, the claims may include aportion and/or the entire item unless specifically stated to thecontrary.

Any reference to a specific direction, for example, references to up,upper, down, lower, and the like, is to be understood for illustrativepurposes only or to better identify or distinguish various componentsfrom one another. Any reference to a first or second vertebra orvertebral body is intended to distinguish between two vertebrae and isnot intended to specifically identify the referenced vertebrae asadjacent vertebrae, the first and second cervical vertebrae or the firstand second lumbar, thoracic, or sacral vertebrae. These references arenot to be construed as limiting in any manner the medical devices and/ormethods as described herein. Unless specifically identified to thecontrary, all terms used herein are used to include their normal andcustomary terminology. Further, while various embodiments of medicaldevices having specific components and structures are described andillustrated herein, it is to be understood that any selected embodimentcan include one or more of the specific components and/or structuresdescribed for another embodiment where possible.

What is claimed is:
 1. A method for positioning a load-bearing componentof an orthopedic implant, comprising: providing a malleable device, thedevice including a biocompatible sheath and more than one curablematerials sealed within the sheath, each of the curable materials havingat least one different curing characteristic, the device having anon-rigid form and being transformable to a rigid form after applicationof a quantity of an initiating energy to the material effective to curethe material; applying a dose of the initiating energy to the curablematerials after the curable materials are sealed within thebiocompatible sheath; and after said applying, inserting the device withthe curable materials sealed within the biocompatible sheath to an invivo location where the provision of load-bearing functionality isdesired, wherein the biocompatible sheath is transparent or translucentto the initiating energy, and wherein the device further comprises areinforcement member contained within the sheath to provide additionalstrength after curing.
 2. The method in accordance with claim 1 whereinthe device is deformable before and during said inserting.
 3. The methodin accordance with claim 1 wherein said providing comprises providingthe device in a compacted configuration for delivery to the in vivolocation.
 4. The method in accordance with claim 3, further comprising,after said inserting, reforming the device into an expanded form that islarger than the compacted form in at least one dimension.
 5. The methodin accordance with claim 4 wherein the compacted configuration comprisesa folded configuration, and wherein said reforming comprises unfolding.6. The method in accordance with claim 4 wherein the compactedconfiguration comprises a flexed configuration.
 7. The method inaccordance with claim 6 wherein said applying occurs prior to flexingthe device.
 8. The method in accordance with claim 1, furthercomprising, after said inserting, forming the device to a desired shapeand a desired orientation relative to a bony portion.
 9. The method inaccordance with claim 1, further comprising, after said inserting,maintaining the malleable device in the desired orientation for a periodof time sufficient for the curable materials to harden, thereby forminga load-bearing component of an orthopedic implant.
 10. The method inaccordance with claim 1 wherein the device is sterilized.
 11. The methodin accordance with claim 1 wherein said providing comprises removing thedevice from a sealed package.
 12. The method in accordance with claim 11wherein the package is sterilized.
 13. The method in accordance withclaim 1 wherein said applying comprises exposing the curable materialsto the initiating energy for a time period of from about 1 second toabout 30 minutes.
 14. The method in accordance with claim 1 wherein saidapplying comprises exposing the curable materials to the initiatingenergy for a time period of from about 5 seconds to about 5 minutes. 15.The method in accordance with claim 1 wherein, after said applying, thedevice has a working time prior to fully transforming to the rigid formof from about 1 minute to about 60 minutes.
 16. The method in accordancewith claim 1 wherein, after said applying, the device has a working timeprior to fully transforming to the rigid form of at least about 2minutes.
 17. The method in accordance with claim 1 wherein the curablematerials include a single component epoxy.
 18. The method in accordancewith claim 1 wherein the initiating energy is selected from the groupconsisting of electromagnetic radiation, thermal energy, electricalenergy, chemical energy and mechanical energy.
 19. The method inaccordance with claim 18, wherein the electromagnetic radiation isselected from the group consisting of visible light, ultraviolet light,infrared light, gamma radiation, X-ray radiation and radio frequencyradiation.
 20. The method in accordance with claim 18 wherein saidmechanical energy is ultrasonic energy.
 21. The method in accordancewith claim 1 wherein the sheath is structured to transmit the initiatingenergy therethrough.
 22. The method in accordance with claim 1 whereinthe sheath is composed of a self-sealing material, and wherein saidapplying comprises injecting into the curable materials a dose of achemical initiator effective to initiate curing.
 23. The method inaccordance with claim 1 wherein the device, upon transformation of thecurable materials to the rigid form, becomes a load-bearing componentselected from the group consisting of a spinal rod, a plate, a spacer, abone screw, an anchor, an artificial disk and a nucleus implant.
 24. Themethod in accordance with claim 1 wherein the curing is achieved at atemperature of from about 20° C. to about 70° C.
 25. The method inaccordance with claim 1 wherein the sheath comprises a bioresorbablematerial.
 26. The method in accordance with claim 1 wherein the sheathcomprises a material selected from the group consisting of polyethylene,polyester, polyamide, polyurethane, silicone, polyetheretherketone,polyacrylate, polylactide and polyglycolide.
 27. The method inaccordance with claim 1 wherein the reinforcement member is a structuralmatrix material.
 28. The method in accordance with claim 1 wherein thematrix material comprises a carbon fiber matrix.
 29. The method inaccordance with claim 1 wherein the device comprises a pressurizeableballoon positioned within the sheath and having a fluid-infusing portpassing through the sheath; and wherein the method further comprises,before the curable materials are hardened, infusing a fluid into theballoon to pressurize the balloon, thereby expanding the device in atleast one dimension.
 30. The method in accordance with claim 29 whereinthe device, upon transformation of the material to the rigid form,becomes a member selected from the group consisting of an interbodydevice and a spinal rod.
 31. A method for positioning a load-bearingorthopedic implant, comprising: providing a malleable device includingmore than one curable materials contained within a biocompatible sheath,each of the curable materials having at least one different curingcharacteristic, and an energy delivery element contained within thesheath; initiating curing of the curable materials after the curablematerial is inserted into the biocompatible sheath by exposing thecurable materials contained within the biocompatible sheath to aquantity of initiating energy from the energy delivery element effectiveto initiate curing; and after said initiating, positioning the devicewith the curable materials contained within the biocompatible sheath inan in vivo position, wherein the biocompatible sheath includes areflective internal surface such that the energy is reflected onto thecurable materials, and wherein the device further comprises areinforcement member contained within the sheath to provide additionalstrength after curing.
 32. The method in accordance with claim 31wherein the energy delivery element comprises an electromagneticradiation delivery element, and wherein the internal surface is orientedtoward the curable materials, and wherein the internal surface iseffective to reflect at least a portion of the electromagneticradiation.
 33. The method in accordance with claim 32 wherein theelement is a fiber optic element.
 34. The method in accordance withclaim 32, further comprising connecting a source of electromagneticradiation to the delivery element.
 35. The method in accordance withclaim 31 wherein the energy delivery element is formed as a coil in thematerial.
 36. The method in accordance with claim 31 wherein the energydelivery element comprises at least one link passing through the sheathfor connection to an external energy source.
 37. The method inaccordance with claim 31 wherein the curable materials comprise aphotocurable composition, wherein the energy delivery element comprisesa fiber optic element, and wherein the sheath includes at least onelight portal for transmitting light into the fiber optic cable.
 38. Themethod in accordance with claim 31 wherein the device further comprisesa plurality of energy delivery members positioned within the sheath. 39.A method for positioning a load-bearing orthopedic implant, comprising:providing a malleable device including a biocompatible sheath and morethan one curable materials separately contained therein that arehardenable by exposing the curable materials to a quantity of initiatingenergy effective to fully cure the curable materials, each of thecurable materials having at least one different curing characteristic,wherein the initiating energy is electromagnetic radiation of apredetermined wavelength, and wherein the sheath is translucent ortransparent to the radiation; initiating curing of the curable materialsafter the curable materials are inserted into the biocompatible sheathby passing radiation of the predetermined wavelength through the sheathto expose the curable materials contained within the biocompatiblesheath to a dose of initiating energy effective to initiate curing; andafter said initiating, positioning the device with the curable materialscontained within the biocompatible sheath in an in vivo position,wherein the device further comprises a reinforcement member containedwithin the sheath to provide additional strength after curing.
 40. Amethod for positioning a load-bearing orthopedic implant, comprising:providing a malleable device including a biocompatible sheath and,contained within the sheath, a pressurizeable balloon and more than onecurable materials separately contained therein and positioned externalto the balloon, each of the curable materials having at least onedifferent curing characteristic; initiating curing of the curablematerials after the curable materials are inserted into thebiocompatible sheath by exposing the curable materials contained withinthe biocompatible sheath to a dose of initiating energy effective toinitiate curing; after said applying, positioning the device with thecurable materials contained-within the biocompatible sheath in an invivo position; and after said positioning, introducing a pressurizingfluid into the balloon to pressurize the balloon and exert an outwardpressure on the curable materials and the sheath, thereby causing thedevice to engage adjacent structures, wherein the biocompatible sheathis transparent or translucent to the initiating energy, and wherein thedevice further comprises a reinforcement member contained within thesheath to provide additional strength after curing.
 41. The method inaccordance with claim 40 wherein the device becomes a bone anchor or aninterbody device upon transformation of the material to the rigid form.